Discontinuation of etanercept after achievement of sustained remission in patients with rheumatoid arthritis who initially had moderate disease activity—results from the ENCOURAGE study, a prospective, international, multicenter randomized study

Modern Rheumatology

Volumn 26, Issue 5, 2016, Pages 651-661

  Yamanaka, Hisashi ^a   Nagaoka, Shouhei ^b   Lee, Soo Kon ^c   Bae, Sang Cheol ^d   Kasama, Tsuyoshi ^e   Kobayashi, Hitomi ^f,t   Nishioka, Yuichi ^g   Ueki, Yukitaka ^h   Seto, Yohei ^a   Nishinarita, Makoto ⁱ   Tamura, Naoto ^j   Kimura, Noriko ^k   Saito, Kazuyoshi ^l   Tomita, Tetsuya ^m   Nawata, Yasushi ⁿ   Suzuki, Sadahiro ^o   Ishigatsubo, Yoshiaki ^p   Munakata, Yasuhiko ^q,u   Makino, Yuichi ^r   Inoue, Eisuke ^s   Tanaka, Yoshiya ^l   Takeuchi, Tsutomu ^k   more..

^a TOKYO WOMEN'S MEDICAL UNIVERSITY   (Japan)

^b Yokohama Minami Kyosai Hospital   (Japan)

^c Yonsei University College of Medicine   (South Korea)

^d Hanyang University Hospital for Rheumatic Diseases   (South Korea)

^e SHOWA UNIVERSITY HOSPITAL   (Japan)

^f Itabashi Chuo Medical Center   (Japan)

^g Nishioka Clinic for Rheumatic Diseases and Allergic Diseases   (Japan)

^h SASEBO CHUO HOSPITAL   (Japan)

ⁱ Nishinarita Clinic   (Japan)

^j JUNTENDO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^k KEIO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^l UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH   (Japan)

^m OSAKA UNIVERSITY HOSPITAL   (Japan)

ⁿ Chibaken Saiseikai Narashino Hospital   (Japan)

^o Department of Orthopaedic Surgery   (Japan)

^p YOKOHAMA CITY UNIVERSITY HOSPITAL   (Japan)

^q Taihakusakura Hospital   (Japan)

^r ASAHIKAWA MEDICAL COLLEGE   (Japan)

^s NATIONAL CENTER FOR CHILD HEALTH AND DEVELOPMENT   (Japan)

^t NIHON UNIVERSITY   (Japan)

^u Munakata Yasuhiko Clinic   (Japan)

more..

Author keywords

Clinical trial; Discontinuation; Etanercept; Remission; Rheumatoid arthritis

Indexed keywords

ETANERCEPT; METHOTREXATE; ANTIRHEUMATIC AGENT;

ADULT; ARTICLE; CLINICAL STUDY; CONTROLLED STUDY; DAS28; DISEASE ACTIVITY; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; HEALTH ASSESSMENT QUESTIONNAIRE; HUMAN; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; OPEN STUDY; PHYSICAL DISABILITY; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; REMISSION; RHEUMATOID ARTHRITIS; TREATMENT RESPONSE; AGED; ARTHRITIS, RHEUMATOID; CLINICAL TRIAL; COMBINATION DRUG THERAPY; JAPAN; PROCEDURES; SEVERITY OF ILLNESS INDEX; SOUTH KOREA; TREATMENT OUTCOME; TREATMENT WITHDRAWAL;

ADULT; AGED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DRUG THERAPY, COMBINATION; ETANERCEPT; FEMALE; HUMANS; JAPAN; MALE; METHOTREXATE; MIDDLE AGED; PROSPECTIVE STUDIES; REMISSION INDUCTION; REPUBLIC OF KOREA; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; WITHHOLDING TREATMENT;

EID: 84951265153     PISSN: 14397595     EISSN: 14397609     Source Type: Journal    
DOI: 10.3109/14397595.2015.1123349     Document Type: Article

References (30)

1. D.Aletaha, J.Smolen, M.M.Ward Measuring function in rheumatoid arthritis:identifying reversible and irreversible components. Arthritis Rheum. 2006;54:2784–92.
2. J.Callhoff, A.Weiß, A.Zink, J.Listing Impact of biologic therapy on functional status in patients with rheumatoid arthritis–a meta-analysis. Rheumatology (Oxford). 2013;52:2127–35.
3. H.Yamanaka, E.Inoue, G.Singh, E.Tanaka, A.Nakajima, A.Taniguchi,. Improvement of disease activity of rheumatoid arthritis patients from 2000 to 2006 in a large observational cohort study IORRA in Japan. Mod Rheumatol. 2007;17:283–9.
4. H.Yamanaka, Y.Seto, E.Tanaka, T.Furuya, A.Nakajima, K.Ikari,. Management of rheumatoid arthritis:the 2012 perspective. Mod Rheumatol. 2013;23:1–7.
5. J.L.Nam, S.Ramiro, C.Gaujoux-Viala, K.Takase, M.Leon-Garcia, P.Emery,. Efficacy of biological disease-modifying antirheumatic drugs:a systematic literature review informing the 2013 update of the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis. 2014;73:516–28.
6. A.Lethaby, M.A.Lopez-Olivo, L.Maxwell, A.Burls, P.Tugwell, G.A.Wells Etanercept for the treatment of rheumatoid arthritis. Cochrane Database Syst Rev. 2013 May 31;5:CD004525.
7. T.Möttönen, L.Paimela, M.Leirisalo-Repo, H.Kautiainen, J.Ilonen, P.Hannonen Only high disease activity and positive rheumatoid factor indicate poor prognosis in patients with early rheumatoid arthritis treated with “sawtooth” strategy. Ann Rheum Dis. 1998;57:533–9.
8. K.Michaud, G.Wallenstein, F.Wolfe Treatment and nontreatment predictors of health assessment questionnaire disability progression in rheumatoid arthritis:a longitudinal study of 18,485 patients. Arthritis Care Res. (Hoboken). 2011;63:366–72.
9. J.S.Smolen Treat-to-target:rationale and strategies. Clin Exp Rheumatol. 2012;30(Suppl 73):S2–6.
10. K.Yoshida, Y.K.Sung, A.Kavanaugh, S.C.Bae, M.E.Weinblatt, M.Kishimoto,. Biologic discontinuation studies:a systematic review of methods. Ann Rheum Dis. 2014;73:595–9.
11. Y.Tanaka, S.Hirata Is it possible to withdraw biologics from therapy in rheumatoid arthritis? Clin Ther. 2013;35:2028–35.
12. Y.Tanaka, S.Hirata, B.Saleem, P.Emery Discontinuation of biologics in patients with rheumatoid arthritis. Clin Exp Rheumatol. 2013;31(Suppl 78):S22–7.
13. J.S.Smolen, P.Nash, P.Durez, S.Hall, E.Ilivanova, F.Irazoque-Palazuelos,. Maintenance, reduction, or withdrawal of etanercept after treatment with etanercept and methotrexate in patients with moderate rheumatoid arthritis (PRESERVE):a randomised controlled trial. Lancet. 2013;381:918–29.
14. P.Emery, M.Hammoudeh, O.FitzGerald, B.Combe, E.Martin-Mola, M.H.Buch,. Sustained remission with etanercept tapering in early rheumatoid arthritis. N Engl J Med. 2014;371:1781–92.
15. Y.Tanaka, T.Takeuchi, T.Mimori, K.Saito, M.Nawata, H.Kameda,. Discontinuation of infliximab after attaining low disease activity in patients with rheumatoid arthritis:RRR (remission induction by Remicade in RA) study. Ann Rheum Dis. 2010;69:1286–91.
16. M.van den Broek, N.B.Klarenbeek, L.Dirven, D.van Schaardenburg, H.M.Hulsmans, P.J.Kerstens,. Discontinuation of infliximab and potential predictors of persistent low disease activity in patients with early rheumatoid arthritis and disease activity score-steered therapy:subanalysis of the BeSt study. Ann Rheum Dis. 2011;70:1389–94.
17. S.Hirata, K.Saito, S.Kubo, S.Fukuyo, Y.Mizuno, S.Iwata,. Discontinuation of adalimumab after attaining disease activity score 28-erythrocyte sedimentation rate remission in patients with rheumatoid arthritis (HONOR study):an observational study. Arthritis Res Ther. 2013;15:R135.
18. Y.Tanaka, S.Hirata, S.Kubo, S.Fukuyo, K.Hanami, N.Sawamukai,. Discontinuation of adalimumab after achieving remission in patients with established rheumatoid arthritis:1-year outcome of the HONOR study. Ann Rheum Dis. 2015;74:389–95.
19. J.S.Smolen, P.Emery, R.Fleischmann, R.F.van Vollenhoven, K.Pavelka, P.Durez,. Adjustment of therapy in rheumatoid arthritis on the basis of achievement of stable low disease activity with adalimumab plus methotrexate or methotrexate alone:the randomised controlled OPTIMA trial. Lancet. 2014;383:321–32.
20. N.Nishimoto, K.Amano, Y.Hirabayashi, T.Horiuchi, T.Ishii, M.Iwahashi,. Drug free REmission/low disease activity after cessation of tocilizumab (Actemra) Monotherapy (DREAM) study. Mod Rheumatol. 2014;24:17–25.
21. Y.Matsuda, G.Singh, H.Yamanaka, E.Tanaka, W.Urano, A.Taniguchi,. Validation of a Japanese version of the Stanford Health Assessment Questionnaire in 3,763 patients with rheumatoid arthritis. Arthritis Rheum. 2003;49:784–8.
22. S.C.Bae, E.F.Cook, S.Y.Kim Psychometric evaluation of a Korean Health Assessment Questionnaire for clinical research. J Rheumatol. 1998;25:1975–9.
23. G.Sakellariou, C.A.Scirè, S.M.Verstappen, C.Montecucco, R.Caporali In patients with early rheumatoid arthritis, the new ACR/EULAR definition of remission identifies patients with persistent absence of functional disability and suppression of ultrasonographic synovitis. Ann Rheum Dis. 2013;72:245–9.
24. F.Wolfe, K.Michaud Proposed metrics for the determination of rheumatoid arthritis outcome and treatment success and failure. J Rheumatol. 2009;36:27–33
25. T.Koike, M.Harigai, S.Inokuma, K.Inoue, N.Ishiguro, J.Ryu,. Postmarketing surveillance of the safety and effectiveness of etanercept in Japan. J Rheumatol. 2009;36:898–906.
26. F.Iannone, E.Gremese, G.Gallo, P.Sarzi-Puttini, C.Botsios, F.Trotta,. High rate of disease remission in moderate rheumatoid arthritis on etanercept therapy:data from GISEA, the Italian biologics register. Clin Rheumatol. 2014;33:31–7.
27. E.Keystone, B.Freundlich, M.Schiff, J.Li, M.Hooper Patients with moderate rheumatoid arthritis (RA) achieve better disease activity states with etanercept treatment than patients with severe RA. J Rheumatol. 2009;36:522–31.
28. D.van der Heijde, L.Klareskog, R.Landewé, G.A.Bruyn, A.Cantagrel, P.Durez,. Disease remission and sustained halting of radiographic progression with combination etanercept and methotrexate in patients with rheumatoid arthritis. Arthritis Rheum. 2007;56:3928–39.
29. V.K.Ranganath, P.Maranian, D.A.Elashoff, T.Woodworth, D.Khanna, T.Hahn,. Comorbidities are associated with poorer outcomes in community patients with rheumatoid arthritis. Rheumatology (Oxford). 2013;52:1809–17.
30. V.P.Bykerk, E.Lie, S.J.Bartlett, R.Alten, A.Boonen, R.Christensen,. Establishing a core domain set to measure rheumatoid arthritis flares:report of the OMERACT 11 RA Flare Workshop. J Rheumatol. 2014;41:799–809.